Associate Director, Global Clinical Operations Data Management

Telix Pharmaceuticals Limited; United States; Remote; USD 80,000 - 140,000; Full time

Job summary

Join a dynamic and fast-growing company dedicated to precision medicine. As the Associate Director of Global Clinical Operations Data Management, you will play a pivotal role in ensuring the integrity and quality of clinical trial data. This position involves developing processes for data management, overseeing compliance with regulatory standards, and collaborating with cross-functional teams to deliver impactful results. You will be part of a supportive and engaged team committed to improving the quality of life for patients with cancer and rare diseases. Embrace the opportunity to make a significant difference in the field of oncology and be part of a mission-driven organization that values diversity and innovation.

Benefits

Competitive salaries

Annual performance-based bonuses

Equity-based incentive program

Generous vacation

Paid wellness days

Support for learning and development

Qualifications

• 9+ years of experience in clinical trial data management.
• Strong understanding of GCP and regulatory guidelines.
• Experience in managing imaging data preferred.

Responsibilities

• Manage clinical trial data ensuring compliance with regulatory standards.
• Coordinate data transfers and maintain data integrity.
• Provide training and support on data management processes.

Skills

Clinical Trial Data Management

Regulatory Compliance

Data Quality Assurance

Interpersonal Communication

Leadership

Process Mapping

Attention to Detail

Education

Bachelor’s degree in Health Information Management

Advanced degree (preferred)

Tools

Electronic Data Capture (EDC) Software

Electronic Trial Master File (eTMF)

Imaging Storing Software

Job description

Unsolicited job offers that attempt to phish for personal data have become increasingly prevalent online. Telix does not make any offers outside the official application process and will not make unsolicited contact.

Genuine vacancies are only posted on our website and official social media accounts.

Associate Director, Global Clinical Operations Data Management

USA- Remote Updated: Friday 11 April 2025

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

Under the direction of the VP of Global Clinical Operations, the role must successfully deliver all data management deliverables, meeting internal and external Company Objectives.

The Associate Director, Global Clinical Operations Data Management will act as the clinical data steward and play a crucial role in ensuring the integrity, quality, and compliance of clinical trial data throughout its lifecycle. The role will be responsible for understanding and implementing regulatory guidelines, developing processes and procedures for data transfers, storage and maintenance, managing data transfers, and serving as a steward of data quality and integrity.

The role will work closely with our internal clinical team and external organisations to maintain accurate data and facilitate multi-centre data collation.

Key Accountabilities:

• Data Management and Integrity: Manage clinical trial data in compliance with regulatory standards including but not limited to International Conference on Harmonisation - Good Clinical Practice (ICH-GCP), European Medicines Agency (EMA) guidelines for data archival, and 21CFR Part 11 and Part 312. Ensure data accuracy, completeness, and consistency throughout the data lifecycle.
• Data Stewardship: Serve as a steward of clinical trial data, overseeing data quality, integrity, and security. Develop and implement data governance processes to maintain high-quality data.
• Data Transfer Management: Coordinate data transfers between external vendors and the sponsor organization. Ensure that data transfers comply with regulatory requirements, including 21CFR Part 11 and Part 312, and are conducted securely and efficiently.
• Documentation and Compliance: Maintain comprehensive documentation of data management activities and ensure compliance with regulatory guidelines, including 21CFR Part 11 and Part 312, and internal SOPs.
• Development of Procedures for Collection of Images and Imaging Data: Develop procedures for the collection, archival, and management of imaging data in clinical trials. Ensure compliance with regulatory standards and industry best practices for imaging data.
• Development of Procedure for Clinical Data Collection, Archival and Management: Develop and/or update processes and procedures related to data management and transfer.
• Training and Support: Provide training and support to team members and external stakeholders on data management processes, guidelines, and best practices. Conduct training sessions to ensure understanding and adherence to data management protocols.
• Quality Assurance: Perform data quality checks, identify discrepancies or issues, and implement corrective actions as needed. Conduct audits and inspections to ensure data integrity and compliance.
• Collaboration: Collaborate with cross-functional teams including clinical operations, biostatistics, and regulatory affairs to ensure alignment on data management processes and requirements.
• Contributes to the development of the Data Management Plan and associated documents.
• Performs other duties as assigned.

Education and Experience:

• Bachelor’s degree in Health Information Management, Life Sciences or equivalent work experience. Advanced degree preferred.
• 9+ years of experience in clinical trial data management; 3 to 5 years’ experience managing imaging data.
• 4+ years of leadership experience.
• Experience in process mapping and improvement, preferred.
• Demonstrated understanding of GCP and applicable national and international regulations guiding research and health information management.
• Experience in the use of Electronic Data Capture (EDC) Software, electronic Trial Master File (eTMF) and imaging storing softwares.
• Accuracy, strong attention to detail, highly developed organisational skills and proven ability to establish priorities, manage tasks, exercise sound judgement and work to multiple, tight and conflicting deadlines.
• Excellent interpersonal, verbal and written communication skills with sound negotiating and conflict resolution skills and a demonstrated level of tact and discretion.
• Demonstrated ability to work productively both independently and as part of a team, taking initiative and exercising sound judgement in resolving matters that may arise as part of normal daily work.
• Knowledge of patient/clinical confidentiality protocols.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected.
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges.
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do.
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
• Ethical behaviour: Act with integrity and demonstrate a commitment to ethical behaviour in all interactions with colleagues and stakeholders.
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.